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Virtual Reality Mindfulness Meditation for ACL Injury
N/A
Recruiting
Led By Shelby E Baez, Ph.D., ATC
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, a total of approximately 3 years.
Awards & highlights
Study Summary
This trial will test whether virtual reality mindfulness meditation can help patients after ACLR by reducing fear, improving movement patterns, and improving brain activity.
Who is the study for?
This trial is for females aged 14-25 who had left-side ACL reconstruction surgery 1 to 5 years ago, are right-hand dominant, and injured their knee in sports. They must have MRI compliance, specific levels of fear related to movement (measured by a special scale), and poor jump-landing patterns. Excluded are males, those with recent concussions or CNS medications, claustrophobia, metal implants that can't be removed, under drug influence or pregnant.Check my eligibility
What is being tested?
The study tests if virtual reality mindfulness meditation helps reduce injury-related fear, improves jump-landing movements and brain activity after ACL surgery compared to a sham VR experience. Participants will be divided into two groups: one experiencing the meditation VR and the other a fake version.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like virtual reality experiences rather than drugs or surgeries, significant side effects aren't expected. However, participants might experience discomfort from wearing VR headsets or motion sickness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, a total of approximately 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, a total of approximately 3 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Injury-related fear as measured by the Tampa Scale of Kinesiophobia-11
Mean Acceptability Survey Score
Percentage of participants retained in the study
+1 moreSecondary outcome measures
Change in Mean percent Blood Oxygen Level Dependent signal in Default Mode Network.
Change in external knee abduction moment
Change in knee flexion excursion
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VR Mindfulness Meditation GroupExperimental Treatment1 Intervention
Participants will complete 8-weeks of virtual reality mindfulness meditation and an advanced neuromuscular training program. Mindfulness meditation is the practice of sustaining attention on the body, breath, or sensations in any given moment and allows for the self-regulation of attention by decreasing rumination about past or future events. During the practice of mindfulness meditation, the individual is aware of all incoming thoughts and feelings, but rather than reacting to them, the individual accepts them. Virtual reality mindfulness meditation has been demonstrated to be superior in inducing mindfulness states when compared to traditional mindfulness meditation. Use of a virtual reality system to implement mindfulness meditation not only decreases the barrier of time to implement psychological interventions, but also improves the clinician's confidence in implementing the intervention as the virtual reality system guides the patient through the mindfulness meditation process.
Group II: VR Sham GroupPlacebo Group1 Intervention
Participants will complete 8-weeks of virtual reality sham and an advanced neuromuscular training program. Participants will be immersed in a virtual environment but will not receive the mindfulness meditation.
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Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,797 Total Patients Enrolled
4 Trials studying Anterior Cruciate Ligament Injury
1,376 Patients Enrolled for Anterior Cruciate Ligament Injury
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,994 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Injury
129 Patients Enrolled for Anterior Cruciate Ligament Injury
Shelby E Baez, Ph.D., ATCPrincipal InvestigatorUNC-Chapel Hill
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a neurological condition like epilepsy.I am taking medication that affects my brain or nerves.I have had ACL reconstruction surgery on my left knee.I am female.I am between 14 and 25 years old.I have been told I land poorly when I jump.I am male.I had ACL reconstruction surgery between 1 and 5 years ago.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the trial protocol include participants under 20 years of age?
"This medical trial is exclusively open to patients aged 14-25. Moreover, there are 47 clinical trials for minors and 25 such trials catered specifically towards the elderly population."
Answered by AI
Are new participants being accepted for this investigation?
"The data hosted on clinicaltrials.gov implies that this trial is not actively enrolling patients at the moment, having been posted on January 1st 2023 and last updated November 1st 2022. Nevertheless, there are still 100 other studies taking in participants currently."
Answered by AI
Could I be a participant in this clinical experiment?
"The medical trial is currently recruiting 48 individuals, aged 14 to 25, with a previous anterior cruciate ligament injury. Participants must be female and right-hand dominant, who have experienced the injury within 1 - 5 years prior when playing or training for sports (recreational or organized). Moreover, they must demonstrate magnetic resonance imaging compliance as well as self-reported fear on the Tampa Scale of Kinesiophobia-11 and poor jump landing movement quality measured by the Landing Error Scoring System – Real Time."
Answered by AI
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